MAUDE Adverse Event Report: COVIDIEN SURGICAL HUGO¿ RAS SYSTEM; MODULAR ELECTROMECHANICAL SURGICAL SYSTEM

Model Number	MRASI0001
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pre-operatively during docking, the monopolar curved shears(mcs) failed to attach to the instrument drive unit(idu), resulting in an error message stating "instrument error" immediately after insertion.The mcs was inserted three times, each time followed by the same error, and the system did not recognize the mcs.The sterile interface module(sim) was also reattached, but the error persisted.A new instrument was used, which operated properly.It took 10 minutes to resolve the issue.There was no patient involvement.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H2) additional information: d9, h10 h3) device evaluation: medtronic led an evaluation of the reported monopolar curved shears and the associated device logs.Visual inspection of the returned monopolar curved shears noted no corrosion on the electrical contacts.There was no damage noted to the jaws or of the drive cables.Functionally, the jaws were manipulated into multiple position in order to inspect the cables.The jaws were able to achieve each position fully with no difficulty.Electrical testing was performed and the monopolar curved shears were read with no observed failures.Evaluation of the logs indicated several instances of the instrument read / write sequence failing on the monopolar curved shears and sterile interface module (sim).This triggered an error code for 'greater than 60 seconds without instrument communication', which reports an error message stating, "caution: instrument error.Detach instrument; clean and dry attachment contact surfaces.If error persists, discard instrument.".And an error code was triggered for 'no attached instrument - motion limits', which reports an error message stating, "insertion disabled.If docked, attach supported instrument.If draping/un-docked, open port latch to move instrument drive unit.".When these errors occur, the instrument drive unit (idu) cannot be inserted due to no instrument being attached, indicating an instrument connectivity issue.Evaluation of the monopolar curved shears confirmed the reported condition, however, the investigation concluded there were no abnor malities that would have caused or contributed to the reported condition; therefore, the investigation was not able to identify a root cause.However, the most likely cause could be traced to an instrument and sim connectivity issue.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that pre-operatively during docking, the monopolar curved shears(mcs) failed to attach to the instrument drive unit(idu), resulting in an error message stating "instrument error" immediately after insertion.The mcs was inserted three times, each time followed by the same error, and the system did not recognize the mcs.The sterile interface module(sim) was also reattached, but the error persisted.A new instrument was used, which operated properly.It took 10 minutes to resolve the issue.There was no patient involvement.

• Brand Name: HUGO¿ RAS SYSTEM
• Common Device Name: MODULAR ELECTROMECHANICAL SURGICAL SYSTEM
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24754563
• Report Number: 1219930-2026-02096
• Device Sequence Number: 21009389
• Product Code: SCV
• UDI-Device Identifier: 10884521826694
• UDI-Public: (01)10884521826694(11)250715(20)13
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K250725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MRASI0001
• Device Catalogue Number: MRASI0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown